Valerie Neff Newitt
March 2025—Revised requirements in the 2024 edition of the CAP accreditation all common and laboratory general checklists address the activity menu, alternative performance assessment, the quality management system, and infectious disease reporting, among other things.
“When we make revisions in the requirements, we do it for good reason,” says Stephen J. Sarewitz, MD, advisor to and immediate past chair of the CAP Checklists Committee. “In many cases it is to clarify something that was unclear” and raised questions. “In other cases, a change addresses an area in which laboratories get deficiencies, which we are trying to prevent. We also want to reflect state-of-the-art laboratory medicine. As it advances, the checklists are revised accordingly.”
The details related to the new and revised requirements in microbiology, transfusion medicine, clinical chemistry, diagnostic immunology, and flow cytometry, as well as those related to personnel and point-of-care testing, were reported in recent issues (https://bit.ly/CT_1224-staffreq; https://bit.ly/CT_0125-POCreq; https://bit.ly/CT_0225-CHMplus; https://bit.ly/CT_0225-MIC-TRM). The 2024 checklist edition was released Dec. 26.
GEN.13806 Quality Management System requires the laboratory to have a document that describes the overall QMS, which is a set of policies, processes, procedures, and resources designed to ensure high quality in the services provided. In this requirement, Dr. Sarewitz says, a paragraph has been added about the need to integrate the laboratory’s QMS “with that of the umbrella organization, assuming the lab is part of a larger organization.”
If so, the laboratory’s QMS must describe the process the lab uses to communicate quality monitors or concerns appropriate for the organization’s overall quality management program. The requirement says the process may include participation in a medical executive committee or the organization’s quality management reporting structure, or communication can take place by the lab interacting directly with other departments. Examples of lab quality initiatives that may be reported through this process are unexpected postoperative diagnoses, blood component usage, and test ordering practices.
GEN.41316 Significant Infectious Disease Diagnoses requires the laboratory to ensure communication of diagnoses of infectious diseases of particular significance to the physician or other clinical personnel responsible for patient care and to retain records of these communications.
“The essence of this requirement has not changed. It’s just more explicit,” Dr. Sarewitz says. An appropriate notification includes a direct dialog with the responsible individual or an electronic communication (secure email or fax) with confirmation that the person received the notification. The record of the communication may be included directly on the patient report or in a separate location.
“The main point of this requirement,” he explains, “is not that these diagnoses be critical results—that’s a separate issue that is up to the laboratory director—but that the lab has some assurance that the result has been received” by the person responsible for the patient’s care.
Referral laboratories can report these results to the referring lab or directly to the responsible clinical personnel per the written agreement the two laboratories have for results related to significant infectious disease diagnoses.
GEN.41318 Reporting and Submission of Materials to Public Health Authorities is a new requirement, the purpose of which is to separate the reporting to public health authorities from the reporting to clinical personnel. Separating the two “gives us a bucket into which we can drop specific text if and when there’s a future public health emergency,” Dr. Sarewitz explains. Previously, this requirement was part of GEN.41316.
GEN.77400 Emergency Eyewash requires the laboratory to have adequate plumbed or self-contained emergency eyewash facilities safely placed in every area where exposure to the eye from corrosive chemicals may occur.
“The small but important revision is that the eyewash needs to be ‘safely placed,’ the point being that ideally it should not be by a sink, for example, where chemicals and biologic materials are disposed of,” Dr. Sarewitz says. It is the responsibility of the inspector to determine if the eyewash location is acceptable.
“We recognize this is a plumbing issue in some cases,” he adds, “so a lab might not be able to immediately make the correction” and would have to “come back with a plan to fix it.”
Several requirements in the all common checklist were revised in response to frequently asked questions and to address commonly cited deficiencies.
“Activity menu citations are one of the top 10 deficiencies cited every year,” Dr. Sarewitz says, adding that the CAP has learned that the problem stems in part from difficulty understanding how to list the testing activities. “So we’ve added elements to the requirement to reduce confusion.”
One such element is that the test must be listed on the activity menu “whether or not the laboratory uses the CAP’s proficiency testing program for a particular test,” he says. Another is that the laboratory’s instrument list is independent from the activity menu. Thus, this requirement should not be cited if the instrument list is incorrect.
A third element says the CAP master activity menu should represent only those analytes that are measured directly. Calculations are not to be included, with three exceptions: nonwaived INR, calculated hematocrit, and estimated hemoglobin.
A fourth says testing performed under a separate CLIA certificate must not be listed on the laboratory’s activity menu. “You don’t want to commingle the tests on the activity menu. It should be just the tests that are done under one CLIA number,” Dr. Sarewitz explains.
Also made clear is that laboratories are not required to include on their activity menus testing performed solely for the purpose of research, though the lab can do so if it wants the CAP to inspect such testing. “If the testing is used to make a patient decision, it should be on the activity menu,” he says.
Included on the menu should be activities related to remote review and interpretation of digitized images and data under the laboratory’s CAP/CLIA certificate.
COM.01500 Alternative Performance Assessment has a minor change to the requirement for semiannual alternative assessment for those tests for which the CAP does not require proficiency testing. A new note in COM.01500 says calculated test results derived from directly measured results (O2 saturation, for example) do not require proficiency testing or alternative assessment, with the exception of the same three cited in the activity menu requirement: nonwaived calculated INR, calculated hematocrit, and estimated hemoglobin. Proficiency testing or alternative performance assessment requirements apply to the measured analytes used to obtain the calculated result.
COM.01700 PT and Alternative Performance Assessment Result Evaluation requires ongoing evaluation of both by the laboratory director or designee and corrective action for unacceptable results. Some laboratories have questioned how long they have to investigate the unacceptable result and implement a corrective action. “We had considerable discussion about this and decided we couldn’t come up with a specific time frame,” Dr. Sarewitz says, “because it might depend on any number of situations and variables.” Thus, the requirement now says the time frame for investigation “should be appropriate for the determination of any impact on patient results.”
“That’s a judgment the inspector will have to make,” Dr. Sarewitz notes.
Among the other all common checklist requirements that were revised for clarity is COM.04250 Comparability of Instruments and Methods—Nonwaived Testing.
It says if the lab uses more than one nonwaived instrument/method to test for a given analyte, it must check the instruments and methods against each other at least twice a calendar year for comparability of results.
“This is a requirement that sometimes has been difficult to interpret,” Dr. Sarewitz says. The clarification is that the requirement does not apply to instruments or equipment that do not provide a reportable result, such as microscopes and stainers. “There’s nothing to compare,” he notes.
COM.30600 Maintenance/Function Checks, which requires the checks and the records for them, now makes it clear that equipment not in use doesn’t require maintenance or function checks, but that the checks must be performed before the equipment is returned to service. “Self-evident but sometimes not understood,” Dr. Sarewitz says.
COM.30750 Temperature Checks also is straightforward but a source of some questions, he says, and thus made more explicit. “When we talk about temperature-dependent environments, we mean areas of the laboratory where an instrument is operating, where there’s a temperature range in which the instrument is allowed to operate or where specific reagents are stored at room temperature, so that it’s important to understand what the ambient temperature is,” he says. In addition, “you must know what the temperature is when storing reagents or patient specimens even when your lab is closed.” A continuous monitoring device or minimum-maximum thermometer makes it possible to check that the temperature was not out of range when the laboratory was closed, he says.
The final revised requirements in the all common checklist pertain to contract research organization laboratories.
“A question has come up: Does the laboratory need to validate or verify a test onsite for contracted research?” Dr. Sarewitz says. COM.40300 Verification of Test Performance Specifications—FDA-Cleared/Approved Tests now has a note for contract research organization laboratories that says for tests performed strictly for research purposes, the lab may accept verification studies performed by the sponsor or manufacturer contracting with the lab. Records have to be maintained showing attestation by the manufacturer (or contractor) that the test was verified and how the test is used, with attestation that it’s used for research only and will not be accessible for clinical purposes. If the test is used in any way to make a decision for an individual patient, however, such as eligibility for a research trial, then onsite verification by the laboratory is required.
The same note now is in two other requirements: COM.40325 Verification of Test Performance Specifications—Tests Approved by an Internationally Recognized Regulatory Authority—Laboratories Not Subject to U.S. Regulations, and COM.40350 Validation of Test Performance Specifications—Modified FDA-Cleared/Approved Tests and LDTs.
Valerie Neff Newitt is a writer in Audubon, Pa.